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Active, not recruiting Phase 2 Interventional Results available

Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

ClinicalTrials.gov ID: NCT02712723

Public ClinicalTrials.gov record NCT02712723. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 6:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Femara (Letrozole) Plus Ribociclib (LEE011) or Placebo as Neo-adjuvant Endocrine Therapy for Women With ER-positive, HER2-negative Early Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

Study identification

NCT ID
NCT02712723
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Qamar Khan
Other
Enrollment
121 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2016 (Actual)
Primary completion
Aug 27, 2018 (Actual)
Completion
Dec 2026 (Estimated)
Last update posted
Mar 11, 2026

2016 – 2026

United States locations

U.S. sites
13
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
City of Hope National Medical Center Duarte California 91010 —
Cancer Research Collaboration Santa Ana California 92705 —
University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach Florida 33442 —
University of Kansas Cancer Center - West Kansas City Kansas 66112 —
University of Kansas Cancer Center - Overland Park Overland Park Kansas 66210 —
University of Kansas Cancer Center - Westwood Westwood Kansas 66205 —
Massachusetts General Hospital Boston Massachusetts 02114 —
University of Kansas Cancer Center - South Kansas City Missouri 64131 —
University of Kansas Cancer Center - North Kansas City Missouri 64154 —
University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri 64064 —
Columbia University Medical Center New York New York 10032 —
University of Wisconsin Carbone Cancer Center Madison Wisconsin 53705 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02712723, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 11, 2026 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02712723 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →